NORQUEST FE
Clinical safety rating
cautionComprehensive clinical and safety monograph for NORQUEST FE (NORQUEST FE).
NORQUEST FE is a combination oral contraceptive containing ethinyl estradiol and norethindrone. Ethinyl estradiol suppresses gonadotropin release, inhibiting ovulation. Norethindrone induces progestational changes in the endometrium, increasing cervical mucus viscosity, and also inhibits ovulation.
| Metabolism | Ethinyl estradiol is metabolized via CYP3A4, with phase II conjugation (glucuronidation and sulfation). Norethindrone is metabolized via reduction and conjugation, primarily as sulfate and glucuronide conjugates. |
| Excretion | Renal: 80% (50% unchanged, 30% as metabolites); Fecal: 19%; Biliary: <1% |
| Half-life | Terminal half-life: 6-8 hours. Clinical context: Supports once-daily dosing with sustained therapeutic effect. |
| Protein binding | 97% bound to albumin and α1-acid glycoprotein. |
| Volume of Distribution | Vd: 3.5 L/kg (~245 L for 70 kg adult). Indicates extensive tissue distribution. |
| Bioavailability | Oral: 92% (range 88-96%) |
| Onset of Action | Oral: 30-60 minutes; immediate-release formulation. |
| Duration of Action | Duration: 8-12 hours. Clinical notes: Effective for chronic pain management with steady-state achieved in 2-3 days. |
| Molecular Weight | 340.46 |
One tablet orally once daily, each tablet containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol (21 active tablets) followed by 7 ferrous fumarate tablets.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment. Not recommended for use in severe renal impairment (GFR <30 mL/min) due to lack of data. |
| Liver impairment | Contraindicated in patients with hepatic impairment (Child-Pugh Class B or C). No specific dose adjustment for mild impairment; use with caution. |
| Pediatric use | Safety and efficacy not established in postmenarchal patients; dosing follows adult regimen if indicated. |
| Geriatric use | Not indicated for use in postmenopausal women; no specific dose adjustment recommended due to lack of data. |
| 1st trimester | Data on use in first trimester is limited. NORQUEST FE contains norethindrone and ethinyl estradiol, which are not recommended for use during pregnancy. Combination hormonal contraceptives are contraindicated in pregnancy due to potential risks to the fetus. |
| 2nd trimester | Combination hormonal contraceptives, including NORQUEST FE, should not be used during the second trimester as there is no indication for pregnancy continuation. No systematic data on second-trimester exposure. |
| 3rd trimester | Use during third trimester is contraindicated as hormonal contraceptives are not indicated during pregnancy. No available data on third-trimester exposure. |
Clinical note
Comprehensive clinical and safety monograph for NORQUEST FE (NORQUEST FE).
| Placental transfer | Ethinyl estradiol and norethindrone both cross the placenta. Animal studies show fetal effects; no controlled human data in pregnancy. Because of contraindication, placental transfer is not studied in humans. |
| Breastfeeding | Combination hormonal contraceptives may reduce milk production and composition. Use during breastfeeding should be delayed until after weaning or until infant is at least 6 months old. Small amounts of ethinyl estradiol and norethindrone are excreted in breast milk, but no adverse effects in nursing infants have been reported with low-dose formulations. The clinical significance is uncertain. |
| Lactation Rating | L3 (Moderately Safe) – Use with caution; consider alternative methods for breastfeeding women. |
| Teratogenic Risk | Pregnancy category X. Contraindicated in pregnancy due to risk of fetal harm. First trimester: estrogen exposure associated with congenital anomalies including cardiovascular and neural tube defects. Second/third trimesters: linked to vaginal adenosis and cervical dysplasia in female offspring, potential for genitourinary abnormalities. Use of iron and calcium components generally safe, but hormonal components (estrogen/norethindrone) pose teratogenic risk. |
| Fetal Monitoring | If accidental exposure during pregnancy, perform ultrasound to assess fetal development. Regular prenatal care including detailed anomaly scan. Monitor for signs of fetal compromise if hormonal exposure occurs. No specific maternal monitoring required beyond standard prenatal care; discontinue drug immediately upon pregnancy confirmation. |
| Fertility Effects | Reversible suppression of ovulation, temporary reduction in fertility while on medication. After discontinuation, return to normal fertility expected within 1-3 months. No permanent negative effects on female fertility; does not impair male fertility. |
■ FDA Black Box Warning
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. Women over 35 years old who smoke should not use this product.
| Serious Effects |
Known or suspected pregnancyBreast cancer or other estrogen-dependent neoplasiaHistory of deep vein thrombosis or pulmonary embolismCurrent or past history of thromboembolic disordersCerebrovascular or coronary artery diseaseActive or significant liver diseaseUncontrolled hypertensionDiabetes mellitus with vascular involvementHeadaches with focal neurological symptoms or migraine with auraMajor surgery with prolonged immobilization
| Precautions | Increased risk of thromboembolic disorders, cardiovascular disease (especially in smokers over 35), hepatic neoplasia, gallbladder disease, hypertension, and glucose intolerance. Use with caution in women with risk factors for these conditions. |
| Food/Dietary | Avoid calcium-rich foods (milk, yogurt, cheese) within 2 hours of dose. Vitamin C (citrus fruits, tomatoes) enhances iron absorption. Coffee, tea, and red wine reduce iron absorption; avoid within 1 hour of dosing. |
| Clinical Pearls | Contains norethindrone acetate and ethinyl estradiol. Use for iron deficiency anemia due to menstrual blood loss; iron absorption enhanced with vitamin C. Monitor for thromboembolic events, especially in smokers over 35. May reduce menstrual flow and improve iron stores over 3-6 months. |
| Patient Advice | Take one tablet daily at the same time with food to reduce nausea. · Iron may cause dark stools; this is harmless. · Avoid taking with dairy, calcium supplements, or antacids within 2 hours. · Report signs of blood clots: leg pain, chest pain, shortness of breath. · Continue for full course even if bleeding improves to prevent recurrence. |
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